Type 1 DiabetesPhase 2INS1GHTNCT07247734
The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
A Phase 2 study testing Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks and Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks in people with Type 1 Diabetes and Chronic Inflammation, run by Asger Lund, MD at 1 site in Denmark.
Trial summary
The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 1 Diabetes, Chronic Inflammation, Insulin Sensitivity
- What is being tested?
- Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks and Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2025to 22 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid <200 pmol/L
- Age 18-80 years
- User of a continuous glucose monitor (CGM) system
- Glycated hemoglobin A1c (HbA1c) 42-75 mmol/mol
- Stable insulin therapy (defined as no change in insulin brand and no newly initiated Continuous subcutaneous insulin infusion (CSII) or Multiple dose injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitor or intermittently scanned continuous glucose monitor) ≥ 3 months with either multiple daily injections or continuous subcutaneous insulin infusion
- Estimated glomerular filtration rate ≥ 60 mL/min/L/1.73 m²
- Estimated glucose disposal rate (eGDR)* < 8 mg/kg/min OR insulin usage of ≥1 IU/kg pr day
- C-reactive protein (CRP) hsCRP ≥ 2 mg/L, (measured by high-sensitivity assay)**
Who cannot join
- Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose monitor with alarm function
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive)
- History of cirrhosis, chronic active hepatitis, or severe hepatic disease
- Inflammatory bowel disease or chronic diarrhoea
- Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels > three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
- Cancer or lymphoproliferative disease unless in complete remission for > 5 years
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- Blood dyscrasias (e.g., myelodysplastic syndromes or related haematological disorders)
- Leukocyte cell count < 3.0 X 109/L
- Thrombocyte count < 110 X 109/L
- Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV)
- Treatment with anti-inflammatory drugs (e.g., non-steroidal anti-inflammatory drugs (NSAID), acetylsalicylic acid (ASA), prednisone) or whole-body topical steroid during the study or within four weeks before study start. Inhaled steroids are allowed. Short term oral NSAID treatment (≤ 3 days) within four weeks before study start or during the study period is allowed. Treatment of ASA is allowed for up to 1000 mg daily.
- Treatment with colchicine within 60 days of screening visit
- Known or suspected hypersensitivity to colchicine
- Treatment with glucose lowering drugs other than insulin (e.g., Glucagon Like Peptide 1 (GLP-1) receptor agonists, metformin, selective sodium glucose cotransporter-2 (SGLT2)-inhibitors) during the study period or within four weeks before study start
- Haemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion)
- Treatment with a P-glycoprotein inhibitor (e.g., azithromycin and verapamil) or a strong CYP3A4 inhibitor (e.g., clarithromycin and ritonavir)
- Intake of grapefruit juice
- Other concomitant disease or treatment that according to the investigator's assessment makes the individual unsuitable for study participation
- Alcohol/drug abuse (assessed by the investigator)
- Regarding fertile women:
- A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- Sterilised or postmenopausal women (no menses for 12 months without an alternative medical cause) can be included without the human chorionic gonadotrophin (hCG)-testing during the trial period
- Women who are pregnant, intend to become pregnant, or are breastfeeding will not be included in the study
- Female of childbearing potential: must use highly effective contraceptives during the trial and three months after the trial. To exclude pregnancy, urine hCG tests are performed in relation to all visits (V1-V5) and to the phone call in the washout period (P2) and there will be instructions to ensure monthly testing three months after the end of the trial.
- The following contraceptive methods are considered highly effective and thus adequate for study enrolment for females if maintained throughout the study duration and three months after the trial: Combined hormonal contraception associated with inhibition of ovulation (containing estrogen and progestogen administered oral, intravaginal or transdermal). Progestogen-only hormonal contraception associated with inhibition of ovulation (admninistered oral, injectable or implantable). Intrauterine device (IUD). Intrauterine hormone-releasing system. Bilateral tubal occlusion. Vasectomised partner. Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
- Male participants with partners of childbearing potential: must either use a condom or ensure that their partner uses a highly effective contraceptive method during the trial and six months after the trial.
- Pregnant or nursing women
- Participants unable to speak or understand Danish
- Receipt of any investigational drug within 30 days prior to visit 1
- Simultaneous participation in any other clinical intervention trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region 2900
Gentofte Municipality, 2400
Asger B Lund, MD, PhD, 004538674266, asger.lund.01@regionh.dk
Aske N Høck, MD, 004561275585, aske.nicolai.hoeck@regionh.dk
About this study
Official title: The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation: A Randomized, Double-Blind, Placebo-Controlled, Investigator-Initiated Trial
The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.
- Conditions
- Type 1 Diabetes, Chronic Inflammation, Insulin Sensitivity
- Being tested
- Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks, Placebo once daily for two weeks, then twice daily for two weeks, Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeksDrug
Also called Colrefuz
Colchicine treatment in the first period
Placebo once daily for two weeks, then twice daily for two weeksDrug
Placebo treatment in the first period
Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeksDrug
Colchicine treatment in the second period
Placebo once daily for two weeks, then twice daily for two weeksDrug
Placebo treatment in the second period
| Study group | Role | What they receive |
|---|---|---|
| Colchicine first period, placebo second period | Active comparator | Colchicine daily for 4 weeks, followed by an 8-week washout period, then placebo for 4 weeks. Receives: Drug: Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks; Drug: Placebo once daily for two weeks, then twice daily for two weeks |
| Placebo first period, colchicine second period | Active comparator | Placebo for 4 weeks followed by an 8-week washout period, then Colchicine daily for 4 weeks. Receives: Drug: Placebo once daily for two weeks, then twice daily for two weeks; Drug: Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference in M-value
Mean difference in insulin sensitivity is measured by the M-value (glucose infusion rate mg/kg/min) during the last 30 minutes of a 180 minutes hyperinsulinemic euglycemic clamp procedure using insulin infusion rate of 60 mU/m²/min
Measured: Four weeks of treatment comparing colchicine to placebo.
Secondary outcomes (8)
Mean difference in M-value
Measured in mg/m²/min. Adjusted to body surface area (BSA)
Measured: After four weeks of placebo/colchicine
Mean difference in M-value (adjusted to fat free mass (FFM))
Measured in mg/kg FFM/min
Measured: After four weeks of placebo/colchicine
Mean difference in Insulin Sensitivity Index (ISI)
Glucose infusion rate / Plasma insulin in steady state
Measured: After four weeks of placebo/colchicine
Mean difference in average daily insulin dosage
Units/day. Total daily dose, short acting, long acting
Measured: During four weeks of placebo/colchicine
Fold difference in Insulin sensitivity by estimated glucose disposal rate (eGDR)
Ratio. It is calculated using clinical variables such as waist circumference, hypertension status, and HbA1c. Higher eGDR values indicate better insulin sensitivity
Measured: After four weeks of placebo/colchicine
Fold difference in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)
Ratio
Measured: After four weeks of placebo/colchicine
Fold difference in in fasting serum/plasma concentrations iInterleukin 6 (IL-6) (pg/mL)
Ratio
Measured: After four weeks of placebo/colchicine
Fold difference in in fasting serum/plasma concentrations of tumour necrosis factor alpha (TNF alpha)
Ratio
Measured: After four weeks of placebo/colchicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start1 Dec 2025
- Primary completion22 Dec 2026 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Being a cross-over trial, participants will undergo 2 treatment periods: 4 weeks of treatment with daily colchicine and 4 weeks of treatment with placebo. The order of the treatment periods is randomized 1:1. Each treatment period will be interposed by 8 weeks of wash-out period. In the end of each treatment period the insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asger Lund, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor-investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
- Investigators
- Asger B Lund, MD, PhD, Principal investigator, Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247734
- Sponsor's protocol ID
- 2025-522528-29-00
- Other IDs
- 2025
- Acronym
- INS1GHT
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). While sharing de-identified data may contribute to transparency, reproducibility, and collaborative progress in type 1 diabetes and metabolic research, several factors must be considered. These include ethical and legal obligations related to participant confidentiality, the need for appropriate data-use agreements, and institutional policies on data governance. The possibility of sharing IPD will be revisited upon study completion, in alignment with ethical approvals, and journal publication policies.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation: A Randomized, Double-Blind, Placebo-Controlled, Investigator-Initiated Trial
- ClinicalTrials.gov ID
- NCT07247734
- Acronym / sponsor ID
- INS1GHT / 2025-522528-29-00
- Conditions
- Type 1 Diabetes, Chronic Inflammation, Insulin Sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Asger Lund, MDUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Being a cross-over trial, participants will undergo 2 treatment periods: 4 weeks of treatment with daily colchicine and 4 weeks of treatment with placebo. The order of the treatment periods is randomized 1:1. Each treatment period will be interposed by 8 weeks of wash-out period. In the end of each treatment period the insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.
| Arm | Type | Receives |
|---|---|---|
| Colchicine first period, placebo second period | Active comparator | Drug: Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks, Drug: Placebo once daily for two weeks, then twice daily for two weeksColchicine daily for 4 weeks, followed by an 8-week washout period, then placebo for 4 weeks. |
| Placebo first period, colchicine second period | Active comparator | Drug: Placebo once daily for two weeks, then twice daily for two weeks, Drug: Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeksPlacebo for 4 weeks followed by an 8-week washout period, then Colchicine daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid <200 pmol/L
- Age 18-80 years
- User of a continuous glucose monitor (CGM) system
- Glycated hemoglobin A1c (HbA1c) 42-75 mmol/mol
- Stable insulin therapy (defined as no change in insulin brand and no newly initiated Continuous subcutaneous insulin infusion (CSII) or Multiple dose injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continuous glucose monitor or intermittently scanned continuous glucose monitor) ≥ 3 months with either multiple daily injections or continuous subcutaneous insulin infusion
Key exclusion criteria (30 listed)
- Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose monitor with alarm function
- Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive)
- History of cirrhosis, chronic active hepatitis, or severe hepatic disease
- Inflammatory bowel disease or chronic diarrhoea
- Pre-existing progressive neuromuscular disease or individuals with creatinine kinase levels > three times the upper limit of normal (measured at screening visit with the possibility of one repeat analysis within a week, and the last measured value as being conclusive)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeksAlso: ColrefuzColchicine treatment in the first period | Drug | Colchicine first period, placebo second period |
| Placebo once daily for two weeks, then twice daily for two weeksPlacebo treatment in the first period | Drug | Placebo first period, colchicine second period |
| Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeksColchicine treatment in the second period | Drug | Placebo first period, colchicine second period |
| Placebo once daily for two weeks, then twice daily for two weeksPlacebo treatment in the second period | Drug | Colchicine first period, placebo second period |
Primary outcome
Mean difference in M-value
Time frame: Four weeks of treatment comparing colchicine to placebo.
Mean difference in insulin sensitivity is measured by the M-value (glucose infusion rate mg/kg/min) during the last 30 minutes of a 180 minutes hyperinsulinemic euglycemic clamp procedure using insulin infusion rate of 60 mU/m²/min
8 secondary outcomes
Mean difference in M-value
Time frame: After four weeks of placebo/colchicine
Mean difference in M-value (adjusted to fat free mass (FFM))
Time frame: After four weeks of placebo/colchicine
Mean difference in Insulin Sensitivity Index (ISI)
Time frame: After four weeks of placebo/colchicine
Mean difference in average daily insulin dosage
Time frame: During four weeks of placebo/colchicine
Fold difference in Insulin sensitivity by estimated glucose disposal rate (eGDR)
Time frame: After four weeks of placebo/colchicine
Fold difference in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L)
Time frame: After four weeks of placebo/colchicine
Fold difference in in fasting serum/plasma concentrations iInterleukin 6 (IL-6) (pg/mL)
Time frame: After four weeks of placebo/colchicine
Fold difference in in fasting serum/plasma concentrations of tumour necrosis factor alpha (TNF alpha)
Time frame: After four weeks of placebo/colchicine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). While sharing de-identified data may contribute to transparency, reproducibility, and collaborative progress in type 1 diabetes and metabolic research, several factors must be considered. These include ethical and legal obligations related to participant confidentiality, the need for appropriate data-use agreements, and institutional policies on data governance. The possibility of sharing IPD will be revisited upon study completion, in alignment with ethical approvals, and journal publication policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asger B Lund, MD, PhD principal investigator
Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks and Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks in people with Type 1 Diabetes and Chronic Inflammation, run by Asger Lund, MD at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Askee N. Høck, MD (+4561275585, aske.nicolai.hoeck@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in M-value (time frame: Four weeks of treatment comparing colchicine to placebo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.